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Medizintechnik

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Draft standard 2024-09

DIN 91422:2024-09 - Draft
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite

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Standard [CURRENT] 2017-05

DIN EN 15224:2017-05
Quality management systems - EN ISO 9001:2015 for healthcare; German version EN 15224:2016

This European Standard specifies requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or ...

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Standard [CURRENT] 2023-02

DIN EN ISO 13131:2023-02
Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021); English version EN ISO 13131:2022

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Draft standard 2024-10

DIN EN ISO 21388-2:2024-10; VDE 0753-388-2:2024-10 - Draft
Acoustics - Hearing Aid Fitting Management - Part 2: Tele-services as part of hearing aid fitting management (tHAFM) (ISO/FDIS 21388-2:2024); German and English version FprEN ISO 21388-2:2024

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Standard [CURRENT] 2023-11

DIN ISO 25551:2023-11
Ageing societies - General requirements and guidelines for carer-inclusive organizations (ISO 25551:2021)

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Standard [CURRENT] 2024-01

DIN ISO 25552:2024-01
Ageing societies - Framework for dementia-inclusive communities (ISO 25552:2022)

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Technical rule [CURRENT] 2023-10

DIN CWA 17502:2023-10
Privacy of monitoring technology - Guidelines for introducing ambient and wearable monitoring technologies balancing privacy protection against the need for oversight and care; German version CWA 17502:2020
Procedure : CWA

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Standard [CURRENT] 2022-06-01

CSA C22.2 No. 60601-1-11:2022-06-01
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Adopted IEC 60601-1-11:2015, edition 2:2015 consolidated with amendment 1:2020, with Canadian deviations)

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Standard [CURRENT] 2022-12-01

CAN/CSA-Z900.1:2022-12-01
Cells, tissues, and organs for transplantation: General requirements

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Standard [CURRENT] 2022-12-01

CAN/CSA-Z900.2.2:2022-12-01
Tissues for transplantation

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